Using sleep study data to predict airway collapse in sleep apnea patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop predictive models for the site of airway collapse in patients with obstructive sleep apnea (OSA) using baseline polysomnography data. It will involve 1000 patients who have undergone a recent polysomnographic study and will receive drug-induced sleep endoscopy (DISE) as part of their standard care. The study will analyze airflow shape patterns from polysomnography to correlate with DISE results, ultimately creating models to identify the site, pattern, and degree of upper airway collapse. The first phase will validate a preliminary model in 300 patients to assess its predictive accuracy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years or older.
* Diagnosis with OSA (AHI ≥ 5).
* Eligible for drug-induced sleep endoscopy as the next step in the clinical path for OSA.
* Capable of giving informed consent.

Exclusion Criteria:

* Diagnostic polysomnography data not available at the Antwerp University Hospital.
* Factors indicative of unstable clinical status or would preclude DISE investigation:
* Medication use related to sleeping disorders.
* Central Sleep Apnea Syndrome.
* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
* Seizure disorders.
* Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
* Pregnancy or willing to become pregnant

Where it's running

• Antwerp University Hospital
  Edegem, Belgium Recruiting

Study contacts

• Principal investigator: Olivier M Vanderveken, MD, PhD — University Hospital, Antwerp
• Study coordinator: Sara Op de Beeck, PhD
• Email: sara.opdebeeck@uza.be
• Phone: 0032 3 821 3385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.